A panel of medical experts has recommended that
Celebrex be made available as a treatment for juvenile rheumatoid arthritis.
The advisers to the Food and Drug Administration voted 15 to 1 Wednesday that Celebrex's potential benefit outweighed both the drug's risks and Pfizer's inability to show convincingly that it was safe for children. Before the final tally, the advisory panel voted 8-7, with one abstention, that Pfizer's testing hadn't clearly proved the drug's safety.
The FDA isn't bound by its panels' recommendations, but the agency usually sides with the outside medical experts. It isn't clear how quickly the FDA will act.
Celebrex is approved for six different indications in the U.S., including osteoarthritis, a degeneration of the joints; rheumatoid arthritis, an inflammatory disease; management of acute pain in adults; and the reduction of certain colon polyps.
The FDA says juvenile rheumatoid arthritis affects 30,000 to 60,000 children across the country, often with "devastating" consequences such as joint swelling, pain and growth abnormalities. There are other drugs, but they may not work well for some patients and could cause "intolerable side effects" for others, the FDA says.
Although some critics say Celebrex should be restricted or even removed from the market, the drug has slowly regained sales even though it carries
tough warnings about cardiovascular and gastrointestinal risks on its label. Older pain relievers also contain similar strong language on their labels.
Celebrex contributed $537 million to Pfizer's third-quarter revenue, up 20% from the same period a year ago. Pfizer predicts full-year sales of $2 billion vs. $1.73 billion in 2005. That's still well below the peak of $3.3 billion in 2004.
The drug's sales took a hit after Celebrex got caught up in the concerns surrounding
decision to remove Vioxx from the market due to the risk of cardiovascular problems. Celebrex and Vioxx belong to a group of pain relievers called COX-2 inhibitors.
On Tuesday, a report by FDA staff members asked if more tests were needed to determine if Celebrex should be approved for juvenile rheumatoid arthritis. Pfizer's application for the new indication used a test between Celebrex and the older pain reliever naproxen. Patients were treated for three to six months. Pfizer succeeded in proving its test goal that Celebrex was as effective as naproxen.
Staff reports are routinely issued before advisory committee meetings, highlighting issues about research and suggesting questions for committee members to ask drugmakers.
FDA staff members said there was "insufficient information" about naproxen as a treatment for juvenile rheumatoid arthritis. Thus, it was "problematic" to design a test for Celebrex using naproxen as a comparison. Also, the Pfizer test guidelines "may not be adequate," the FDA staff report said.
The advisory committee's vote took place after the market had closed. In regular trading, Pfizer's stock gained 2 cents to $27.07.